Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma

ISRCTN	ISRCTN12125882
DOI	https://doi.org/10.1186/ISRCTN12125882
Protocol serial number	2009DR2127
Sponsor	Horten Center, University of Zurich (Switzerland)
Funders	Horten Center, University of Zurich (Switzerland) - core funding, Lucerne Eye Clinic (Switzerland) - core funding, Novartis (Switzerland) - providing active medications

Submission date: 10/08/2010
Registration date: 18/08/2010
Last edited: 26/05/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Frank Bochmann
Scientific

Augenklinik
Luzerner Kantonsspital
CH-6000 Luzern 16
Lucerne
6000
Switzerland

Study information

Primary study design	Interventional
Study design	Phase I: Follow-up study Phase II: Randomised Controlled Trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Influence of topical anti-VEGF (Ranibizumab) on the outcome of filtration surgery for glaucoma: A two phased study with a randomised placebo controlled trial
Study objectives	This is a two phased study in patients who underwent trabelculectomy with mitomycin C combined with phacoemulsification and intra ocular lens (IOL) implantation. 1. Assessing the local tolerability and safety of topical ranibizumab 2. Assessing the efficacy of topical ranibizumab against placebo
Ethics approval(s)	1. The local Ethics committee approved on the 24th of October 2008 2. Swissmedic, the Swiss Food and Drug Administration approved on the 25th of June 2009 (ref: 2009DR2127)
Health condition(s) or problem(s) studied	Glaucoma, patients with excessive wound healing after trabeculectomy.
Intervention	Topical ranibizumab eyedrops (2mg/ml) four times daily for 1 month or placebo (BSS 4x/d for 1 month
Intervention type	Other
Primary outcome measure(s)	Differences in the intraocular eye pressure, measured at 4 weeks, 3 and 6 months
Key secondary outcome measure(s)	1. Bleb appearance / vascularisation using a standardized photography and the Moorfields bleb grading system 2. Postoperative intraocular pressure 3. Conjunctival wound healing problems All outcomes will be measured at 4 weeks, 3 and 6 months.
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Patients with primary open angle glaucoma (POAG), PEX and pigment dispersion Glaucoma 2. At least 18 years of age 3. No previous intraocular surgery undergoing trabeculectomy or phaco-trabeculectomy
Key exclusion criteria	1. Patients with primary angle closure glaucoma (PACG) 2. Glaucoma due to other causes 3. Previous intra- and extraocular surgery 4. Any surgery during the last 3 months 5. Patients with uveitis or inflammatory ocular surface disease 6. Patients with single eyes 7. Patients presenting the first postoperative day with bleb leak, hypotony or situations that potentially need another surgery 8. Pregnant and breast feeding women 9. Women planning to get pregnant
Date of first enrolment	01/01/2011
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Switzerland

Study participating centre

Augenklinik

Lucerne
6000
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	17/01/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes